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CE Marking Medical Devices
CE Marking
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IVDR
Certificates of Free Sale
OEM – Private Labeling
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Declaration of Conformity
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CE Consulting Environmental Requirements – WEEE / RoHS
EU Authorized Representative
European Authorized Representation for Manufacturers of Medical Devices
EU Authorized Representative Responsibilities
EU Authorized Representative vs. Distributor
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Swiss Authorized Representative
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Home
CE Marking Medical Devices
CE Marking
CE Approval
MDR
IVDR
Certificates of Free Sale
OEM – Private Labeling
Technical File Compilation
Declaration of Conformity
CE Consulting Electrical Equipment – EMC / LVD
CE Consulting Environmental Requirements – WEEE / RoHS
EU Authorized Representative
European Authorized Representation for Manufacturers of Medical Devices
EU Authorized Representative Responsibilities
EU Authorized Representative vs. Distributor
UK & Swiss Services
UK Responsible Person (UKRP)
Swiss Authorized Representative
Library
Overview
Download Section
Supportive Information
Link Section
FAQ Section
News
Contact
About Us
Contact Persons
Contact Details
Reviews
Partners & Associates
Author:
Sheila OShaughnessy
Brexit
MHRA draft recognition policy for international approvals
June 22, 2024
Brexit
Great Britain’s plan to accept medical devices registered abroad
August 22, 2023
Brexit
,
News in Brief
UK MHRA gives CE marked devices new transition deadlines
July 4, 2023
News in Brief
Swiss Federal Council to mirror extended transition timelines for MDR legacy devices
June 2, 2023
Brexit
,
News in Brief
UK updated guidance will reflect EU extensions
May 15, 2023
Brexit
UK MHRA’s new and higher charges for medical devices
March 1, 2023
Brexit
Extra year for CE-marked devices to access UK market
January 6, 2023
Brexit
,
News in Brief
Consultation on amending UK medical devices regulations
December 2, 2021
IVDR
,
MDR
,
News in Brief
EU – Switzerland MRA expired
May 27, 2021
Brexit
,
News in Brief
Additional MHRA guidance for medical device companies
January 17, 2021
Brexit
,
News in Brief
Latest UK MHRA updates on Northern Ireland and EU device regulation guidance
October 26, 2020
Brexit
,
News in Brief
New UKCA mark after Brexit
September 17, 2020
Brexit
,
News in Brief
Brexit and the regulatory situation for the medtech industry
February 3, 2020
Brexit
News on Brexit
October 29, 2019
Brexit
New Guidance for the UK Responsible Person Published
September 26, 2019
News in Brief
LRQA to Withdraw Notified Body Services
June 13, 2019
Brexit
Details about the Regulation of Medical Devices in Case of No-Deal Brexit
February 28, 2019
Brexit
Brexit Key Challenges – a Brief Case Study
February 15, 2019
Brexit
What about Brexit?
December 21, 2018